Recently Published European Consensus Guidelines Highlight the Need
for a Bedside Test

November 28, 2016 03:30 AM Eastern Standard Time

LONDON--(BUSINESS WIRE)--SIME
Dx, a digital molecular medicine company developing point-of-care
diagnostics, announced data validating the efficacy of a lung maturity
test (LMT) in identifying infants at risk of respiratory distress
syndrome (RDS) who could benefit from early surfactant treatment. RDS is
a major cause of mortality and morbidity in premature infants. It can be
effectively treated with surfactant, a therapy which reduces the effort
needed to expand the lungs during inspiration and allow gas exchange to
take place. Early surfactant treatment can help prevent the onset and
impact of RDS, however, prophylactic treatment has been shown to be
harmful and only necessary in half of all pre-term infants. The LMT
could allow screening of all pre-term infants for RDS risk. The study,
published online by ACTA Paediatrica, is titled “Rapid
determination of lung maturity in premature infants at birth by
mid-infrared spectroscopy” [doi:10.1111/apa.13683].

“This lung maturity test has been developed to identify pre-term infants
who will benefit from early surfactant treatment. By only rapidly
intervening in those infants who need treatment, we can significantly
improve RDS clinical outcomes, and potentially lessen the need for
mechanical ventilation and oxygen. The need for such a test has been
highlighted in the recently published European Consensus Guidelines on
the Management of RDS1,” explained Prof. Henrik Verder,
Department of Pediatrics, Holbaek University Hospital in Denmark, lead
author of the paper and inventor of the test. “Surfactant treatment
itself is very safe and effective, however, there are risks associated
with the intubation required for administration. This poses the question
of whether the risks of prophylactic surfactant outweigh the benefits
when some infants do not need treatment.”

The LMT is performed on small volumes of gastric fluid (aspirate)
suctioned as part of the routine management of neonates at birth.
Infra-red spectroscopic analysis of this gastric fluid, using a
specially developed machine learning algorithm, determines the
lecithin-sphingomyelin (L/S) ratio in the sample. These are biological
constituents found naturally in the lungs. A low ratio indicates a high
risk of RDS. This method was validated by comparing RDS risk predictions
to actual incidences of RDS in patient samples collected in Denmark,
Sweden and the UK.

“The development of our lung maturity test is the culmination of many
years’ commitment and hard work by several collaborators. It is the
first test resulting from our digital molecular diagnostics (DMDx)
platform, which is able to measure multiple biomarkers from a single
fluid sample, delivering real-time results to clinicians,” stated Povl
Verder, CEO of SIME Dx. “We are currently developing a bedside version
of the test for use in a clinical setting. This will enable us to
validate the test and collect the necessary data for commercialisation.
Furthermore, the company is expanding the (DMDx) platform to apply
cloud-based machine learning, so that in the future the data captured
can be analysed to improve algorithms and develop new test.”

This study was funded by the EU Horizon2020 Phase II SME instrument,
project number 666668.

Developed by world-renowned scientists, the first DMDx application is a
Lung Maturity Test (LMT) for premature infants used to help
neonatologists diagnose Respiratory Distress Syndrome (RDS) minutes
after birth. SIME Dx is a London (UK) and Holbaek (Denmark) based
company part-funded through the EU Horizon2020 Phase II initiative and a
Microsoft Ventures alumnus. Further information can be found at www.simedx.com.